No Failure-to-Warn When Drug Label Is FDA Compliant

Litigation News October 21, 2014

A district court dismissed a product liability lawsuit against a drug manufacturer, concluding that the plaintiff failed to adequately allege a failure-to-warn claim against the company for its drug. In re Fosamax Products Liability Litigation (Gaynor v. Merck Sharp & Dohme Corp.). The district court held that because the drug manufacturer complied with FDA requirements to change its warning label, the plaintiff's failure-to-warn claim failed.

Compliance with FDA Requirements In 1997, the FDA approved Fosamax for the treatment and prevention of osteoporosis in postmenopausal women. In June 2008, the FDA contacted Merck and other manufacturers of bisphosphonate drugs for any investigations they conducted "regarding the occurrence of atypical fractures with bisphosphonate use" and other information, because the FDA was "concerned about this developing safety signal." Merck provided the data shortly thereafter, and the FDA concluded that the data "did not show an increase in . . . [the risk of atypical subtrochanteric femur fractures] in women using these medications".

In September 2008, Merck submitted a supplement to add language to the drug label of a possible risk of atypical fractures with the use of Fosamax. The FDA rejected the label change, concluding that the data did not support a clear connection between the use of bisphosphonates and atypical fractures.

In 2010, an independent research group reported a connection between the use of bisphosphonates and the occurrence of atypical fractures. The FDA then required a label change to indicate that long-term use of the drug (at least three years) might be related to atypical fractures. Merck incorporated this post-label change in January 2011.

Failure to Warn Allegations—Pre-Label and Post-Label Change Cases The plaintiff, Barbara Gaynor, was prescribed Fosamax for her osteoporosis in 1996. She took the drug until September 2011, when she suffered an atypical femur fracture. The plaintiff filed a complaint against Merck, and among the plaintiff's allegations, she asserted that Merck violated failure-to-warn laws in New York.

The court characterized the Gaynor case as a "post-label change" case because her injury arose after September 2010, when the nexus between the drug and atypical femur fractures was first confirmed by an independent medical group. Cases that deal with injuries prior to September 2010 are considered "pre-label change" cases. The court had dismissed "pre-label change cases" in an earlier decision.

The district court granted summary judgment in favor of Merck, holding the plaintiff's allegations were inconsistent. The district court noted that the plaintiff alleged that the drug company's warnings were not adequate, yet later the plaintiff argued that the court should not determine the adequacy of the label because the label itself was not a proximate cause of her injury. The court concluded that the plaintiff did not otherwise meet the requirements of proving the elements of a failure to warn claim.

"The plaintiff tried to convince the court that there was a fact issue regarding whether Merck should be liable for a post-label change injury based on a pre-label change breach while attempting to argue that Merck's post-label change conduct (i.e. the content of the warning) was not relevant," says Richard Gaal, Mobile, AL, cochair of the ABA Section of Litigation's Products Liability Committee. "The court had previously decided that all pre-label change cases were preempted, so pre-label change conduct could not be imported into a post-label change injury case to avoid that preemption," Gaal says. "The arguments were inconsistent," Gaal notes, "because the plaintiff could not bridge the gap from pre-label change conduct to post-label change injury and maintain both breach and proximate cause."

Label Is Adequate as a Matter of Law The court also found as a matter of law that the label was adequate in relation to atypical fractures. "In determining whether an issue of fact exists surrounding the adequacy of a warning, New York courts evaluate the [warning]'s language for its accuracy, clarity and relative consistency. "The district court found that the label was accurate because it was "sufficiently clear as it is direct and unequivocal and sufficiently conveys the risk of [atypical femur fractures] when taking Fosamax" and the warnings "are consistent and precise without any contradictions."

The decision follows on the heels of a decision granting summary judgment for the defendant on federal preemption grounds in the "pre-label change" Fosamax case. Glynn v. Merck Sharp & Dohme, Corp. In Glynn, the district court of New Jersey held that any similar pre-label change cases were preempted as a matter of law, "because clear evidence existed that the FDA would not have approved a stronger warning label as of the date of their injuries."

The FDA's Role Defense attorneys generally applaud the decision, particularly given the court's decisiveness on a motion for summary judgment with no discovery deemed necessary. Plaintiffs' lawyers, on the other hand, take issue with the case, particularly the FDA's role. Gaal notes that "because the FDA has to be reactionary, it cannot act on information until it actually has it."

Gaal observes that the case reinforces previous failure to warn holdings "that say if you can't prove the warning was untimely, inadequate, or not properly communicated, you will have a hard time raising an issue of breach."

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